Overview

This trial is active, not recruiting.

Conditions ulcerative colitis, mesenchymal stem cells, umbilical cord
Treatment umbilical cord mesenchymal stem cells
Phase phase 1/phase 2
Sponsor Qingdao University
Start date September 2010
End date September 2012
Trial size 50 participants
Trial identifier NCT01221428, MSCKJ004

Summary

The purpose of this study is to determine whether umbilical cord Mesenchymal Stem Cells of treatment for ulcerative colitis is safe and effective.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Intravenous infusion of ex vivo cultured umbilical cord mesenchymal stem cells,one week later,conduct intervention operation to inject mesenchymal stem cells to mesenteric artery.
umbilical cord mesenchymal stem cells Mesenchymal Stem Cells
Intravenous infusion of ex vivo cultured umbilical cord mesenchymal stem cells(2*10/7),one week later,conduct intervention operation to inject mesenchymal stem cells to mesenteric artery(1*10/7).

Primary Outcomes

Measure
the result of enteroscopy and pathological report
time frame: 3 months

Secondary Outcomes

Measure
the clinical symptom (including stomachache,abdominal distention,bloody purulent stool)
time frame: 3 months

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - Male or female, 18 years of age or older. - Ulcerative colitis described according to usual criteria. - Refractoriness Ulcerative colitis or unefficient by using other therapy - Signed informed consent form. Exclusion Criteria: - History of neoplasm or hematological disease - Uncontrolled high blood pressure (>180/110) - Severe cardiac insufficiency (New York Heart Association [NYHA] IV) or ejection fraction<30% - Malignant ventricular arrythmia - Deep venous thrombosis during the last 3 months - Active bacterial infection - Body mass index > 35 Kg/m2 - Stroke or myocardial infarction during the last 3 months

Additional Information

Official title Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells Infusion for Ulcerative Colitis
Description Ulcerative colitis is characterized as chronic and nonspecific inflammation of gastroenteritis tract.Nowadays,etiology and pathogenesis of UC have been unclear.Recent basic research has been revealed that stem cell can settle down in epithelium of gastroenteritis tract,which provide a hope for treating the disease.We hope umbilical cord Mesenchymal Stem Cells could not only address the need for epithelial cell replacement but also control of the autoimmune response to mocous membrane of colon.
Trial information was received from ClinicalTrials.gov and was last updated in October 2010.
Information provided to ClinicalTrials.gov by Qingdao University.